Systems and methods for percutaneous suture delivery

ABSTRACT

Systems and methods are provided for percutaneously suturing tissue. An elongated deployment member having a guide member coaxially disposed over a shaft member may be used to carry a needle deployment member. The needle deployment member may be carried at a distal end of the elongated deployment member and include a plurality of needles releasably secured to the needle deployment member, wherein each needle is routed coaxially within the distal end of the needle deployment member. The needle deployment member may further include a needle pusher driven by a link coaxially disposed within the shaft member, wherein the needle pusher is configured to advance each needle through the distal end of the needle deployment member and coaxially over the proximal end of the needle deployment member to position the plurality of needles at a piercing angle in a proximal direction.

RELATED APPLICATIONS

This application claims priority to and benefit of U.S. ProvisionalPatent Application Ser. No. 61/768,344, filed Feb. 22, 2013; U.S.Provisional Patent Application Ser. No. 61/781,973, filed Mar. 14, 2013;U.S. Provisional Patent Application Ser. No. 61/824,267, filed May 16,2013; U.S. Provisional Patent Application Ser. No. 61/843,724, filedJul. 8, 2013 and U.S. Provisional Patent Application Ser. No.61/874,057, filed Sep. 5, 2013, the contents all of which areincorporated by reference in their entirety.

FIELD OF THE PRESENT DISCLOSURE

The present disclosure relates generally to techniques and devices forclosing openings in a patient's vasculature or other body lumens. Forexample, the present disclosure relates to systems, devices, and methodsfor percutaneous suturing of arterial and venous puncture sites toapproximate tissue around the opening, such as may be required followinga surgical procedure.

BACKGROUND

To improve recovery time, a variety of interventional and diagnosticprocedures may be carried out in a minimally invasive manner byaccessing a desired location within a patient's body percutaneously. Byintroducing catheters or other elongated devices into the vasculature ata convenient entry point, such procedures may be performed at a remotelocation by guiding the device through the body lumen to the desiredposition. Although these techniques represent less impact on the patientthan conventional open procedures, access to the vasculature requiresforming an opening in an artery or vein that subsequently must berepaired.

A variety of methods may be used to close the access opening.Conventionally, hemostasis may be achieved through manual compression tosubstantially reduce the flow of blood through the opening and allowclot formation. Although generally successful, compression may be take asignificant amount of time and may be associated with considerablepatient discomfort. Additionally, complications such as unintended totalocclusion of the lumen that may result in ischemia or thrombosis canoccur. These aspects may be exacerbated depending upon the size of theopening necessary to introduce the percutaneous device, whetheranticoagulants are employed and on the condition of the patient.

To ameliorate these problems, techniques for suturing the opening toachieve hemostasis and reduce time to ambulation have been developed. Inorder to maintain the minimal invasiveness of the procedure, many ofthese techniques are adapted to be performed percutaneously. Forexample, the suture delivering device may be introduced through the sameopening used to perform the procedure. Typically, one or more needlesare deployed by the suture delivering device to pierce the vessel walland draw the suture material through so that the suture may be securedover the adventitial surface and close the opening. Despite the benefitsassociated with the use of suture delivering devices, a number ofchallenges exist. In particular, it is desirable for the needle orneedles to be positioned accurately with respect to the vessel wall soas to pierce the tissue far enough away from the opening to result in asufficiently robust location for the suture. It is also desirable toprovide a device configured to deploy and actuate the needles in areproducible manner to minimize the amount of skill required from theoperator. Accordingly, this disclosure is directed to systems andmethods for percutaneously suturing an opening in a body lumen whileproviding these and other desired characteristics.

SUMMARY

This disclosure includes a suture delivery device for percutaneouslysuturing tissue. The suture delivery device may include an elongateddeployment member having a guide member coaxially disposed over a shaftmember, a needle deployment member carried at a distal end of theelongated deployment member. The needle deployment member may include alower band configured to retain a non-piercing end of each of theplurality of needles and an upper band configured to position theplurality of needles at the piercing angle when the lower band isactuated by a trigger mechanism. The trigger mechanism includes atrigger link between the needle pusher and a trigger in the handleportion of the device such that the triggering of the trigger mechanismcauses the needle pusher to push the needles towards a needle catcher orneedle receiver located at the distal end of the elongated deploymentmember. The trigger link may include one or more linking mechanismsbetween the needle pusher and the needle catcher/receiver. In thisembodiment, the needle deployment member comprises a needle pusher, atleast one needle, a needle pusher linker, an upper band and a lowerband. The needle pusher may be relatively distal end to lower band. Theneedle pusher and needle linker are contained at the distal end ofneedle deployment member.

In other words, the needle deployment member may include a needle pusherconfigured to retain a non-piercing end of each of the plurality ofneedles that is separate from the lower band. The needle pusher can alsobe the same structure as the lower band. In the embodiment where theplurality of needles is retained in the needle pusher, the lower bandserves as a guide for the plurality of needles to prevent the needlesfrom dislodging or buckling. When the needles are lifted, the needlesextend underneath the lower band and travel over the upper band causingthe needles to protrude out at an angle. The angle of the needle liftingmay be adjusted by the distance between upper band and lower band beforeneedle lifting. The angle of the needle lifting may also be adjusted bychanging the diameter of the upper band.

Alternatively, the needle deployment member may also include a pluralityof or at least one deflectable wings, wherein a proximal end of theneedle deployment member is secured to the guide member and a distal endof the needle deployment member is secured to the shaft member and aplurality of needles releasably secured to the needle deployment member.The needle deployment member may transition between an uncompressedconfiguration corresponding to a first distance between the proximal anddistal ends that longitudinally aligns the plurality of needles with theshaft member and a compressed configuration corresponding to a seconddistance between the proximal and distal ends that positions theplurality of needles at a piercing angle in a proximal direction, thefirst distance being greater than the second distance.

In one aspect, relative longitudinal movement of the shaft member withrespect to the guide member may transition the needle deployment memberbetween the uncompressed and compressed configurations. Further, each ofthe deflectable wings may have a slot configured to carry one of theplurality of needles. In addition, the needle deployment member may havea lower band configured to retain a non-piercing end of each of theplurality of needles and an upper band configured to position theplurality of needles at the piercing angle when in the compressedconfiguration.

In another aspect, the elongated deployment member may also have asheath member coaxially disposed over the guide member, such that thesheath member may extend over a proximal portion of the plurality ofneedles positioned at the piercing angle when the sheath member isadvanced distally over the guide member. Further, the elongateddeployment member may also include a catcher member coaxially disposedbetween the guide member and the sheath member, such that the catchermember captures the plurality of needles positioned at the piercingangle when the catcher member is advanced distally over the guidemember.

As desired, the suture delivery device may have a housing at a proximalend of the elongated deployment member that provides relativelongitudinal movement between the guide member and each of the sheathmember, the catcher member and the shaft member. The housing may beconfigured to store a reproducible amount of tension that may beselectively released to simultaneously move the sheath member distallywith respect to the guide member and the shaft member proximally withrespect to the guide member.

In yet another aspect, the suture delivery device may have a suturecatheter secured to the distal end of the elongated delivery member,wherein the suture catheter carries suture material that may be threadedthrough the plurality of needles. Additionally, the suture catheter maybe secured to the elongated delivery member by a hinge allowing rotationin one direction.

This disclosure also includes methods for delivering a suturepercutaneously. For example, a suitable method may include providing anelongated deployment member having a guide member coaxially disposedover a shaft member, a needle deployment member carried at a distal endof the elongated deployment member, the needle deployment member. In oneaspect, the needle deployment member may include a lower band configuredto retain a non-piercing end of each of the plurality of needles and anupper band configured to position the plurality of needles at thepiercing angle when the lower band is actuated by a trigger mechanism.The trigger mechanism includes a needle pusher linker that links theneedle pusher and a trigger in the handle portion of the device suchthat the triggering of the trigger mechanism causes the needle pusher topush the needles towards a needle catcher or needle receiver located atthe distal end of the elongated deployment member. The needle pusherlinker may include one or more linking mechanisms between the needlepusher and the needle catcher/receiver. In this embodiment, the needledeployment member comprises a needle pusher, at least one needle, aneedle pusher linker, an upper band and a lower band. The needle pushermay be relatively distal end to lower band. The needle pusher and needlepusher linker are contained at the distal end of needle deploymentmember.

The needle deployment member may further include a plurality ofdeflectable wings, wherein a proximal end of the needle deploymentmember is secured to the guide member and a distal end of the needledeployment member is secured to the shaft member and a plurality ofneedles releasably secured to the needle deployment member, advancingthe elongated deployment member percutaneously to a desired position ina patient and withdrawing the shaft proximally relative to the guidemember to transition the needle deployment member from an uncompressedconfiguration that longitudinally aligns the plurality of needles withthe shaft member to a compressed configuration that extends thedeflectable wings positions the plurality of needles at a piercing anglein a proximal direction.

In one aspect, the elongated deployment member may also have a sheathmember coaxially disposed over the guide member, such that advancing thesheath member distally over the guide member to extend over a proximalportion of the plurality of needles positioned at the piercing angle tocause the plurality of needles to pierce tissue sandwiched between theextended deflectable wings and a distal end of the sheath. Advancing thesheath member distally over the guide member and withdrawing the shaftmember proximally within the guide member may be performedsimultaneously. Further, advancing the sheath member distally andwithdrawing the shaft member proximally may be performed by applying anautomatically reproducible amount of force.

In another aspect, the elongated deployment member may also have acatcher member coaxially disposed between the guide member and thesheath member, such that the catcher member may be advanced distallyover the guide member to capture the plurality of needles positioned atthe piercing angle. In addition, the needles may be captured by frictionbetween the distal end of the sheath and a distal end of the catchermember.

In yet another aspect, the shaft member may be advanced distally withrespect to the guide member after the plurality of needles is capturedto transition the needle deployment member to the uncompressedconfiguration. Further, the sheath member and the catcher member may bewithdrawn proximally with respect to the guide member after theplurality of needles is captured.

Additionally, suture material may be carried in a suture cathetersecured to the distal end of the elongated delivery member, wherein thesuture material is threaded through each of the plurality of needles.Further, withdrawing the sheath member and the catcher member may drawthe suture material through the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages will become apparent from the followingand more particular description of the preferred embodiments of thedisclosure, as illustrated in the accompanying drawings, and in whichlike referenced characters generally refer to the same parts or elementsthroughout the views, and in which:

FIG. 1 depicts a partial sectional view of a suture delivery device,according to one embodiment;

FIG. 2 depicts a detail view of the suture delivery device of FIG. 1;

FIG. 3 depicts a further detail view of the suture delivery device ofFIG. 1;

FIG. 4 depicts a needle deployment member in an uncompressedconfiguration, according to one embodiment;

FIG. 5 depicts a needle deployment member in a compressed configuration,according to one embodiment;

FIG. 6 depicts a sheath being extended over needles positioned at apiercing angle by a compressed configuration of the needle deploymentmember, according to one embodiment;

FIG. 7 depicts a housing and handle configuration in an initial state,according to one embodiment;

FIG. 8 schematically depicts the configuration of the needle deploymentmember in the initial state, according to one embodiment;

FIG. 9 depicts a housing and handle configuration during springcharging, according to one embodiment;

FIG. 10 schematically depicts the configuration of the needle deploymentmember in a pre-compressed state, according to one embodiment;

FIG. 11 depicts a housing and handle configuration after springcharging, according to one embodiment;

FIG. 12 depicts a housing and handle configuration after triggeringrelease to fully compress the needle deployment member and advance thesheath, according to one embodiment;

FIG. 13 schematically depicts the configuration of the needle deploymentmember after triggering release, according to one embodiment;

FIG. 14 depicts a housing and handle configuration after advancing thecatcher, according to one embodiment;

FIG. 15 schematically depicts the configuration of the needle deploymentmember after advancing the catcher, according to one embodiment;

FIG. 16 depicts a housing and handle configuration after the handle isreleased, according to one embodiment;

FIG. 17 depicts a housing and handle configuration after the needledeployment member is returned to the uncompressed configuration,according to one embodiment;

FIG. 18 schematically depicts the configuration of the needle deploymentmember after being returned to the uncompressed configuration, accordingto one embodiment;

FIG. 19 depicts details of the connection between an elongated deliverymember and a suture catheter, according to one embodiment;

FIG. 20 depicts a partial cross section of the suture catheter,according to one embodiment;

FIG. 21 depicts an alternative sheath and catcher configuration,according to one embodiment;

FIG. 22 depicts another alternative sheath and catcher configuration,according to one embodiment;

FIG. 23 depicts an alternative catcher configuration, according to oneembodiment;

FIG. 24 depicts a suture locking device, according to one embodiment.

FIG. 25 depicts an alternative suture delivery device, according to oneembodiment;

FIG. 26 depicts a needle pushing element, according to one embodiment;and

FIG. 27 depicts an alternative catheter with a balloon expandable distalregion, according to one embodiment;

FIG. 28 depicts a needle tip and base assembly, according to oneembodiment;

FIG. 29 depicts an embodiment of the needle deployment member withoutdeflectable wings;

FIG. 30 depicts an alternative embodiment of the needle deploymentmember without deflectable wings; and

FIG. 31 depicts the needle deployment member shown in FIG. 30 after theneedles have been fired.

DETAILED DESCRIPTION

At the outset, it is to be understood that this disclosure is notlimited to particularly exemplified materials, architectures, routines,methods or structures as such may vary. Thus, although a number of suchoptions, similar or equivalent to those described herein, can be used inthe practice or embodiments of this disclosure, the preferred materialsand methods are described herein.

It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments of this disclosure only andis not intended to be limiting.

The detailed description set forth below in connection with the appendeddrawings is intended as a description of exemplary embodiments of thepresent disclosure and is not intended to represent the only exemplaryembodiments in which the present disclosure can be practiced. The term“exemplary” used throughout this description means “serving as anexample, instance, or illustration,” and should not necessarily beconstrued as preferred or advantageous over other exemplary embodiments.The detailed description includes specific details for the purpose ofproviding a thorough understanding of the exemplary embodiments of thespecification. It will be apparent to those skilled in the art that theexemplary embodiments of the specification may be practiced withoutthese specific details. In some instances, well known structures anddevices are shown in block diagram form in order to avoid obscuring thenovelty of the exemplary embodiments presented herein.

For purposes of convenience and clarity only, directional terms, such astop, bottom, left, right, up, down, over, above, below, beneath, rear,back, and front, may be used with respect to the accompanying drawings.These and similar directional terms should not be construed to limit thescope of the disclosure in any manner.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one having ordinaryskill in the art to which the disclosure pertains. For example, the term“suturing” includes drawing two surfaces or edges together with aflexible material to close a puncture, opening, or other wound, whereinthe suture is a material that may be synthetic or natural, such as apolymer, gut, metallic wire or other suitable equivalents.

Finally, as used in this specification and the appended claims, thesingular forms “a, “an” and “the” include plural referents unless thecontent clearly dictates otherwise.

According to this disclosure, a device for applying suturespercutaneously to promote hemostasis following an interventionalprocedure may generally include a distal, reconfigurable region thatexhibits a reduced insertion profile and an expanded profile forstabilizing tissue during delivery of the sutures. Relative movementbetween a proximal region of the device and the expanded profile regionmay allow tissue to be secured between the regions and provide a targetfor needle-deployed sutures carried by the device. As will beappreciated from the discussions below, the relative movement betweenthe distal region and the proximal region may involve movement of thedistal region towards the proximal region, movement of the proximalregion towards the distal region, or both. Further, the suture deliverydevices of this disclosure may provide coordinated and/or automaticoperation steps involved in the placement of the sutures, including oneor more of the deployment of the distal region, deployment of theproximal region, securing tissue between the distal and proximalregions, firing of the needles to place the sutures and capture of theneedles after passing through the secured tissue.

FIGS. 1-15 and 19 illustrate an embodiment of the invention wherein theneedle deployment member 110 includes a plurality of deflectable wings.However, as further described herein and shown in FIGS. 29-31, theneedle deployment member 110 does not need to have a plurality ofdeflectable wings in addition to a needle pusher 159, a plurality ofneedles 154, a needle pusher linker 161, an upper band 160 and a lowerband 158. In this embodiment, the needle deployment member may include alower band 158 configured to retain a non-piercing end of each of theplurality of needles 154 and an upper band 160 configured to positionthe plurality of needles at the piercing angle when the needle pusher159 is actuated by a trigger mechanism linked to the needle pusherlinker 161. The trigger mechanism includes a needle pusher linker 161between the needle pusher 159 and a trigger in the handle portion of thedevice (not shown in FIGS. 29-31) such that the triggering of thetrigger mechanism causes the needle pusher 159 to push the needles 154towards a needle catcher or needle receiver (not shown) located at thedistal end of the elongated delivery member 104. The needle pusherlinker 161 may include one or more linking mechanisms between the needlepusher 159 and a trigger in the handle portion of the device. In thisembodiment, the needle deployment member 110 comprises a needle pusher159, at least one needle, a needle pusher linker 161, an upper band 160and a lower band 158. The needle pusher 159 may be relatively distal tolower band 158. The needle pusher 159 and needle pusher linker 161 maybe contained at the distal end of needle deployment member 110.

In an embodiment, the needle pusher 159 and needle pusher linker 161 maybe at distal end of the needle deployment member 110 wherein thedistance between the upper band 160 and the lower band 158 varies orremains relatively constant during operation. In other words, thepiecing of the tissue by the needles is driven by needle pusher 159,which is linked to the proximal end of the device by needle pusherlinker 161. During needle piercing, the distance between upper band 160and lower band 158 may be constant or may decrease. The needle pusher159 may be separate from the lower band 158 and located distal to thelower band 158. In another embodiment, the needle pusher 159 and needlepusher linker 161 may be at distal end of the shaft 134 wherein thedistance between the upper band 160 and the lower band 158 varies orremains relatively constant during operation. In other words, thepiecing of the tissue by the needles 154 is driven by needle pusher 159,which is linked to the proximal end of the device by needle pusherlinker 161. During needle piercing, the distance between upper band 160and lower band 158 may be constant or may decrease. In this embodiment,the needle pusher 159 may be separate from the lower band 158 andlocated distal to the lower band 158. The needle pusher 159 can also belocated adjacent to the lower band 158, depending upon the length of theneedles 154 used. See FIGS. 29 and 30. One skilled in the art canreadily determine the distance between the needle pusher 159 and thelower band 158 in the embodiments wherein the lower band 158 does notalso act as the needle pusher 161.

To summarize, in an embodiment the needle deployment member may includea needle pusher configured to retain a non-piercing end of each of theplurality of needles that is separate from the lower band. The needlepusher can also be the same structure as the lower band. In theembodiment where the plurality of needles is retained in the needlepusher, the lower band serves as a guide for the plurality of needles toprevent the needles from dislodging or buckling. When the needles arelifted, the needles extend underneath the lower band and travel over theupper band causing the needles to protrude out at an angle. The angle ofthe needle lifting may be adjusted by setting initial distance betweenupper band and lower band. The angle of the needle lifting may also beadjusted by changing the diameter of the upper band.

Aspects of this disclosure will now be described in the context of anembodiment shown in FIG. 1. Suture delivery device 100 includes housing102, an elongated delivery member 104 and a distal suture catheter 106for carrying the suture material. In this embodiment, suture catheter106 is joined to the distal end of delivery member 104 through hinge108, that may offer rotation in one direction of up to approximately90°. Needle deployment member 110 is positioned at the distal end ofdelivery member 104, proximal to suture catheter 106. Housing 102includes handle 112 that pivots on axle 114 to drive actuator 116through pin 118 as well as charge spring 120, which is connected atopposing ends to handle 112 by pin 122 and to lever 124, which pivots onaxle 126. As will be described below, interoperation between handle 112,actuator 116 and lever 124 cooperate to sequentially deploy, pierce andcapture suture carrying needles using needle deployment member 110.

Further details regarding delivery member 104 are shown in the partialdetail view of FIG. 2. In this embodiment, delivery member 104 includesan outer tubular sheath 128, coaxially disposed over tubular catcher130, which in turn is coaxially disposed over tubular guide 132 that iscoaxially disposed over shaft 134. Shaft 134 may include bleed backlumen 136 having a distal port 138 and a proximal port 140. As known inthe art, position of delivery member 104, and correspondingly needledeployment member 110, within an artery may be indicated by pulsatileblood flow that enters at distal port 138, is conducted through lumen136 and may be visualized when it exits at proximal port 140. Sheathextension 140 is coupled to lever 124 by pin 142, catcher extension 144is engaged by actuator 116 depending upon the position of handle 112 andshaft extension 146 is coupled to lever 124 by pin 148.

Returning to FIG. 1, pin 150 on handle 112 may engage shaft extension146. Accordingly, sheath 128, catcher 130 and shaft 134 may move axiallywith respect to each other and housing 102 depending upon the motion ofhandle 112 and lever 124, while guide 132 remains stationary withrespect to housing 102.

A more detailed view of the distal end of delivery member 104 is shownin FIG. 3. Needle deployment member 110 is coupled at its proximal endto guide 132 and at its distal end to shaft 134. Relative movementbetween shaft 134 and guide 132 axially compresses needle deploymentmember 110 and causes wings 152 to deflect outwards, extending away fromshaft 134, while needles 154 are positioned at an angle configured topierce the tissue of the vessel wall around the opening. Suitable anglesmay be in the range of approximately 14-20° with respect to shaft 134.In one embodiment, the angle may be approximately 16.3°.

FIGS. 4-6 show a sequence representing compression of needle deploymentmember 110 to position needles 154 at the desired piercing angle andsubsequent capture of needles 154 by friction between sheath 128 andcatcher 130.

Starting with FIG. 4, needle deployment member 110 is shown in itsuncompressed configuration, representing a maximal distance between thedistal ends of shaft 134 and guide 130. Needles 154 are retained axiallywithin slots 156 formed in deflectable wings 152 and releasably securedat their base by lower band 158 of needle deployment member 110. In oneaspect, a desired amount of retention force may be imparted to needles154 by friction with lower band 158. For example, lower band 158 may beconfigured to contact a sufficient surface area of needles 154 toprovide retention. Alternatively, or in addition, the force with whichlower band 158 engages needles 154. Thus, retention of needles 154 maybe achieved by any desired combination of interaction between needles154 and lower band 158 and/or slots 156.

Next, FIG. 5 shows needle deployment member 110 in its compressedconfiguration, achieved by longitudinally withdrawing shaft 134 relativeto guide 130. As shown, wings 152 deflect outwards, while upper band 160at the proximal end of slot 156 engages and lifts needles 154 into theirpiercing angle. A desired piercing angle may also be achieved byadjusting the configuration of needles 154 to control their interactionwith upper band 160. Accordingly, relative motion between upper band 160and lower band 158 may be used to position needles 154 at an appropriatepiercing angle. As will be appreciated, the relative motion betweenupper band 160 and lower band 158 may be achieve by moving lower band158 towards upper band 160, by moving upper band 160 towards lower band158, or both. For example, upper band 160 and lower band 158 have beendescribed as elements of needle deployment member 110. However, inembodiments that employ a different expanding distal region design,upper band 160 and lower band 158 may be provided as independentelements subject to proximal control to position needles 154 at thedesired piercing angle.

In one aspect, deformation areas of wings 152 may be designed atfunctional structure points. The strain may be managed by the thicknessand curvature of slot 156 to lie below its plastic deformation zone,which may be in the range of 6-8%. Lower band 158 holds needles 154within slots 156. The degree to which needles 154 are retained in may beadjusted by varying the height of lower band 158 as described above. Thepiercing angle may be adjusted by varying the distance between lowerband 158 and upper band 160 when needle deployment member 110 iscompressed.

Then, as shown in FIG. 6, sheath 128 may be advanced over the proximalsharp ends of needles 154, sandwiching the tissue of the vessel wallagainst outwardly deflected wings 152. As will be appreciated, needles154 are deployed automatically at the desired angle and interactionbetween wings 152 and sheath 128 provide reproducible conditions forpiercing the tissue of the vessel wall. Needles 154 may be captured byfriction between the inner surface of sheath 128 and the outer surfaceof catcher 130. In the embodiment shown in FIG. 1, sheath 128 isconfigured with an annular rib 162 configured to increase engagementwith needles 154 and augment the capture force provided by sheath 128and catcher 130.

As described above, the devices of this disclosure may be used to closeand facilitate repair of openings created during intravascularprocedures. For example, the Seldinger technique is a known procedurefor accessing the femoral artery and suture delivery device 100 may beused to close the opening created in the artery. More generally, thedevices of this disclosure may be used for percutaneous delivery ofsutures for closing various sizes of vascular access site, and reducingthe time to hemostasis and time to ambulation of patients who haveundergone catheterization procedures using sheaths in the range of 5F-24 F. Still more generally, this disclosure is applicable to anyclinical procedure involving closure of incisions or orifices of softtissues and organs. For example, suture delivery device 100 or anembodiment suitably adapted may be used for closure of soft tissueopening or tear in surgical or interventional procedures such asgastrointestinal perforation, perforated ulcer, closure of trocarincision associated with minimally invasive or natural orificetransluminal endoscopic surgery, closure of patent foramen ovale (PFO),spinal annular repair, and other procedures that may benefit frompercutaneous suturing.

Further details of the disclosure may be appreciated in the context ofexemplary methods for using suture delivery device 100. One embodimentis represented by corresponding sequences of handle positions and needledeployment member configuration that are depicted in FIGS. 7-18.

An initial state of suture delivery device 100 and position of handle112 is shown in FIG. 7 and the corresponding configuration of needledeployment member 110 is shown in FIG. 8. As can be seen in FIG. 7,handle 112 begins at a rightmost position that is extended away fromgrip 164. In this configuration, sheath extension 140 and catcherextension 144 are located at the proximal edge of their respectiveranges of travel so that sheath 128 and catcher 130 are correspondinglyat their most proximal position with respect to guide 132. Shaftextension 146 is at the distal edge of its range of travel, positioningshaft 134 in its most distal position with respect to guide 132. As aresult, needle deployment member 110 is in the uncompressed state shownin FIG. 8. For clarity, the suture catheter 106 portion of suturedelivery device 100 is not shown in the sequence of figures. The distalend of delivery member 104 has been advanced to a location within apatient's vasculature, through an opening in tissue wall 166. In thisembodiment, distal port 138 provides fluid communication to bleed backlumen 136, allowing visualization of pulsatile blood flow to confirm anappropriate position of needle deployment member 110 within a patient'sartery. The position of shaft 134 in its distal position with respect toguide 132 corresponds to the greatest relative distance between lowerband 158 and upper band 160 of needle deployment member 110. Needles 154are positioned against shaft 134 for insertion.

Next, FIG. 9 shows suture delivery device 100 as handle 112 is drawntowards grip 164. Extension of spring 120 charges it, but actuator 116has not yet engaged catcher extension 144. Further, in this embodiment,stop 168 on shaft extension 146 engages release button 170, preventingrelative movement of shaft 134 in the distal direction. As describedabove, lever 124 is coupled to shaft extension 146 through pin 148, suchthat motion of lever 124 is also restrained. If desired, stop 168 may beconfigured to allow some amount of distal travel of shaft 134 before itengages release button 168, resulting in a pre-compression of needledeployment member 110 as shown in FIG. 10. The amount of distal travelallowed to shaft 134 with respect to guide 132 causes a relativedecrease in the distance between lower band 158 and upper band 160.Correspondingly, wings 152 begin to deflect outwardly from shaft 134 andneedles 154 begin to travel from their insertion profile to the piercingangle. The pre-compressed configuration may help maintain position ofneedle deployment member 110 within the body lumen as the increaseddiameter resists withdrawal from the opening in tissue wall.

Handle 112 may then be drawn towards grip 164 to achieve the fullycocked configuration shown in FIG. 11. Pawl 172 engages detent 174 inthis position, providing the user with tactile feedback indicating thata reproducible amount of tension has been applied and stored in spring120. The configuration of pawl 172 resists motion of handle 112 awayfrom grip 164 before completion of the procedure. Since stop 168 engagesrelease button 170, further relative movement of shaft 134, sheath 128or catcher 130 does not occur. Correspondingly, no changes in theconfiguration of needle deployment member 110 occur afterpre-compression.

Full compression of needle deployment member 110 and simultaneouspiercing of tissue wall 166 may be achieved in a reproducible, automaticmanner by triggering release button 170, resulting in the configurationshown in FIG. 12. For example, triggering release button 170 disengagesstop 168 and allows the tension stored in spring 120 to rotate lever124, simultaneously withdrawing shaft 134 in a proximal direction whiledriving sheath 128 in a distal direction, each with respect to guide132. Since handle 112 is positioned at the same location when chargingspring 120 though the interaction of pawl 172 and recess 174, the amountof force that is released and used to drive shaft 134 and sheath 128when button 170 is triggered may be predetermined and tailored toprovide the desired piercing action of needles 154 through tissue wall166. Although actuator 116 is now in contact with catcher extension 144,it has not yet caused relative movement of catcher 130 with respect toguide 132. Further, projection 175 on housing 102 may be configured toprovide resistance to movement of catcher extension 144, so as to keepcatcher 130 in its proximal position even as spring 120 drives sheathextension 140 distally. As shown in FIG. 13, movement of shaft 134 toits most proximal position has fully compressed needle deployment member110 and has deflected wings 152 outwardly while positioning needles 154at the desired piercing angle. Likewise, movement of sheath 128 to itsmost distal position sandwiches tissue wall 166 against wings 152 andcauses needles 154 to pierce tissue wall 166 before entering the lumenof sheath 128.

After needles 154 have pierced tissue wall 166, handle 112 may be drawnto its full range of travel against grip 164 as shown in FIG. 14.Movement of handle 112 to this position drives actuator 116 againstcatcher extension 144, causing catcher 130 to move distally with respectto guide 132. This position of handle 112 also causes stop 176 todeflect pawl 172 towards handle 112, where it may be retained in thedeflected position by hook 178. Engagement of hook 178 provides the userwith an audible and tactile indication that handle 112 has traveled itsfull range of motion and correspondingly, that catcher 130 has beenextended and captured needles 154. As shown in FIG. 15, catcher 130captures needles 154 against sheath 128 when it is extended distally.Catcher 130 may be configured to provide sufficient friction incooperation with sheath 128 to capture needles 154 when extended to itsdistal position to overcome any resistance of lower band 158, allowingneedles 154 to be released from needle deployment member 110. If aneedle 154 is not captured, it may be retained by lower band 158 andsubsequently returned to a position against shaft 134 for removal.

Having reached the end of its stroke, handle 112 may be released andallowed to return to the configuration shown in FIG. 16 due to thetension in spring 120. In this embodiment, no significant movement ofsheath 128, catcher 130 or shaft 134 may occur at this time. Projection175 may provide resistance against catcher extension 144, helping tokeep catcher 130 and sheath 128 in the distal positions. Since pawl 172is secured in its deflected position by hook 178, it does not engagedetent 174 and allows the user to complete the withdrawal sequence bymoving handle 112 to match the position shown in FIG. 17 and decompressneedle deployment member 110. For example, movement of handle 112 to theposition furthest from grip 164 causes shaft extension 146 to driveshaft 134 to its most distal position with respect to guide 132.Simultaneously, shaft extension 146 rotates lever 124, causing sheathextension 140 and sheath 128 to be withdrawn. Interaction between sheathextension 140 and catcher extension 144 causes catcher 130 to bewithdrawn in a coordinated manner. As a result, needle deployment member110 is returned to its uncompressed configuration in which wings 152 aredrawn against shaft 134. Since needles 154 are captured between sheath128 and catcher 130, they are released from lower band 158 of needledeployment member 110 and withdrawn at the same time, pulling suturematerial 180 through tissue wall 166.

Further details regarding the connection between suture catheter 106 anddeployment member 104 are depicted in FIG. 19. As shown, hinge 108 maycouple the distal end of deployment member 104 to suture catheter 106.As desired, hinge 108 may allow rotation in one direction up toapproximately 90°. Rotation in the other direction may be restricted bya stop or other feature to increase pushability of suture catheter 106when traversing through subcutaneous tissue and the vessel wall.Further, rotation in one direction helps align suture delivery device100 with the sagittal plane of the vessel track, while allowingadjustments in insertion angle, such as in the range of approximately45° to 90°. Hinge 108 may be rounded to minimize risk of damage totissue during placement and while performing the procedure. Suturematerial 180 may extend from suture catheter 106 through one or moreports 182 and thread through needles 154. Suture catheter 106 may alsoinclude a guidewire port 184, such as a quick exchange port, tofacilitate use of a guidewire when positioning suture delivery device100 using techniques known in the art.

In other embodiments, suture catheter 106 may employ other suitabledesign configurations to facilitate access to patient's vessel. Forexample, suture catheter 106 may feature an ovalized diameter topreferentially permit flexing about the major axis. Further, thematerial used to form suture catheter 106 may be selected to provide thedesired amount of flexibility of a given application. Suture catheter106 may also exhibit a pre-bent configuration, having an angle ofapproximately 45° or any other suitable angle that may be indicatedbased on the desired application. As yet another example, one or morehinges may be provided in addition to hinge 108 to allow suture catheter106 to take on a desired conformation. In one aspect, suitablemodifications may be made to suture catheter 106 to facilitate access tosmaller vessel diameters.

A partial cross sectional view of suture catheter 106 is shown in FIG.20. In this embodiment, suture catheter 106 has a guidewire lumen 186that communicates with guidewire port 184 and two suture lumens 188 thatcommunicate with suture ports 182. As desired, suture material 180 maybe disposed within suture lumens in any suitable manner. For example,suture material 180 may be carried within suture cartridges that arethen inserted in suture lumens 188, allowing ends of the suture materialto extend out suture port 182 to thread through needle 154. The suturecartridge may be configured to mechanically or chemically apply suturetension when stored within suture catheter 106 to help prevent suturematerial 180 from being pulled out prematurely during insertion ofsuture delivery device 100. Each suture cartridge may have one or morelumens to allow varying lengths of suture material to be carried. Forexample, a single lumen cartridge may carry a suture having a lengthapproximately the same as the length of the cartridge. When a pluralityof lumens is employed, the length of carried suture material may be amultiple of the number of lumens.

Using the techniques of the present disclosure, aspects of suturedelivery device 100 may be embodied in other specific forms. Forexample, another design of catcher and sheath is depicted in FIG. 21. Inthis embodiment, sheath 228 and catcher 230 each have an annular rib,ribs 232 and 234 respectively to facilitate capture and retention ofneedles 154 when catcher 230 is extended distally. In anotherembodiment, instead of using ribs 232 and 234 to further enhanceretention of the needs between catcher 230 and sheath 228, a materialbarrier may be implemented.

Alternatively, as shown in FIG. 22, catcher 330 may have an annular rib332 and sheath 228 may exhibit a relatively straight profile. In yetanother embodiment shown in FIG. 23, catcher 430 may have needlereceiving slots 432 to capture needles 154. As will be appreciated, oneslot may be configured for each needle and may have entrance featuressuch as ramps or inclined planes to guide the needle into the slot.Slots 432 may be tapered to improve capture of needles 154.

The needles are deployed to penetrate tissue and in turn enter needlereceiver/catcher. The needles may be retained in the needlecatcher/receiver by friction. Friction may be provided by variousdesigns, components, and materials. The needle catcher/receiver may bestationary during needle firing or may move distally towards the needledeployment member or may move proximally towards handle. A sheath may beused to guide needle movement (or define the needle movement boundary)along the device longitudinally towards proximal end. For example,friction capture of needle may be created by variable space betweensheath and catcher. Space between sheath and catcher may be wider atneedle entry and narrower at needle capture. Alternatively, spacebetween sheath and catcher may be wider for needle entry and narrowerfor needle capture. In another example, the needle may be captured dueto friction of interaction with material of the needle catcher/receiveror sheath while the space between sheath and needle catcher/receiverdoes not change longitudinally.

The needles may be captured in the needle catcher/receiver passively oractively. In the passive embodiment, there is no component movement orthere is one component movement by either sheath or catcher/receiver.The variable space between the sheath and the catcher/receiver may be afixed gradient. In addition, the space between sheath and catcher may bewider at distal end and narrower at proximal end. Thus, in oneembodiment, the sheath and catcher/receiver remain stationary and theneedles enter into space defined by sheath and the catcher/receiver. Inother words, the needles move distally and are retained by the narrowingspace between sheath and the needle catcher/receiver. In anotherembodiment of the passive method, the sheath moves distally to definespace for receiving the needles. The needles enter into the spacedefined by the sheath and the catcher/receiver and are bound/guided bythe sheath inner-wall. The needles move proximally and are retained bythe narrowing space between the sheath and catcher/receiver. The sheathretracts proximally while the catcher/receiver remains stationary.

In the active embodiment, the space between the sheath andcatcher/receiver may be a dynamic gradient. Relative motion between thesheath and receiver may change during needle movement proximally tocreate narrowing of inter-space between the sheath and needlecatcher/receiver to capture and retain the needles. The sheath andcatcher/receiver may move relative to each other to create more spacefor needle entry into inter-space. The sheath and receiver may moverelative to each other to reduce the inter-space and capture theneedles. In one embodiment, the space between the sheath andcatcher/receiver is opened up while the sheath moves distally to receivethe needles. The space between the sheath and catcher/receiver may bereduced by retracting the sheath proximally while the catcher/receivermoves distally, or by retracting the sheath proximally while thecatcher/receiver remains stationary. In another embodiment, the sheathis positioned against soft tissue. The space between the sheath andcatcher/receiver may be reduced to receive the needles by moving thecatcher/receiver distally.

In another embodiment, the variable space between the sheath andcatcher/receiver may include mechanical engagement to enhance captureand retention of the needles more securely. The sheath may move distallyto define space for receiving the needles. The needles then enter thespace defined by the sheath and the catcher/receiver. The needles movedistally and are retained by the narrowing space between the sheath andcatcher/receiver. The retention of the needles may be enhanced bymechanical compression to engage the needles. Finally, the sheath isretracted proximally while catcher/receiver remains stationary. Onskilled in the art would recognize that other methods of ensuring needlecapture and retention beyond those described herein may be implemented.

As described above, suture delivery device 100 may be employed to closeopenings formed in a body lumen or other tissue. One exemplary routinefor employing device 100 may involve gaining access to a patient'svasculature, such as by using the Seldinger technique. As known to thoseof skill in the art, a Seldinger needle may be introduced into apatient's femoral artery at a suitable location on the thigh. Aguidewire may be advanced through the Seldinger needle to locate aposition within the artery, after which the Seldinger needle is removed.A dilator coaxially disposed within an introducer sheath may be advancedover the guidewire until the distal end of the dilator is positionedwithin the artery. After removal of the dilator, suture delivery device100 may be advanced over guidewire, such as by threading suture catheter106 over the proximal end of the guidewire, which may then exit thoughport 184. Once suture catheter 106 has entered the artery, the guidewiremay be removed.

The distal end of delivery member 104 is then advanced until pulsatileblood is observed exiting from the proximal end of bleed back lumen 136,indicating needle deployment member 110 has been positioned inside thevessel, such that needles 154 are entirely within the femoral artery.Suture delivery device 100 may then be rotated along the vessel sagittalplane from 45° to 90°. The user may then operate handle 112 as indicatedabove with regard to FIGS. 7-18 to perform the suture placementsequence. As described, needle deployment member 110 is compressed whileadvancement of sheath 128 causes needles 154 to pierce tissue wall 166.Following capture of needles 154 between catcher 130 and sheath 128,suture material 180 is pulled through when needle deployment member 110is decompressed. Successful completion of the suture placement sequenceis indicated by a cessation of pulsatile blood flow from bleed backlumen 136. Suture delivery device 100 may then be rotated along thevessel sagittal plane from 90° to 45° and withdrawn, leaving suturematerial 180 deployed through tissue wall 166.

After deployment of suture material 180, any suitable percutaneousprocedure may be performed through the opening. Upon completion of theprocedure, suture material 180 may be tied or otherwise secured toapproximate tissue around the opening. Suture material may be securedthrough use of sliding knots or other suitable techniques. As known inthe art, clips, glue or interlocking devices may be used to secure theends of suture material 180. For example, FIG. 24 depicts a suturelocking device 190 that may be carried on the end of an elongateddelivery member (not shown). Suture locking device 190 may feature anupper disc 192 and lower disc 194 that rotate with respect to eachother. Upper disc 192 and lower disc 194 may have slots 164 that arealigned during delivery. Suture material 180 may be fed through slots196 and suture locking device 190 may be advanced to a desired positionto tension the suture. Subsequent rotation of upper disc 192 and lowerdisc 194 with respect to each other secures suture material 180 byfriction.

Embodiments have been described above in the context of suture deliverydevice 100 that features automatic and coordinated operation of handle112 to produce relative movement between tubular sheath 128, catcher130, guide 132 and shaft 134 to expand needle deployment member 110,sandwich tissue between needle deployment member 110 and sheath 128,pierce the tissue with needles 154 and subsequently catch the needles.As will be appreciated, any of these operations or combinations of theseoperations may be performed independently. One exemplary embodiment isshown in FIG. 25 as suture delivery device 500. Housing 502 may includeproximal actuator 504 that slides to create relative movement at adistal region 506 to create a conformation change between a reducedprofile for insertion and an expanded profile that helps stabilizetissue for suture delivery. Handle 508 may be withdrawn to chargesprings inside handle 502 (not shown) and to provide relative motionbetween distal region 506 and proximal region 510 to engage tissuebetween these elements as described above. Button 512 may release springtension stored by housing 502 to pierce the tissue and place thesutures. In turn, FIG. 26 shows a detail of a needle pushing element 514that may be driven proximally upon release of button 512 to placesutures 516 and 518. Capture of needles 520 may be achieved using anysuitable technique, such as in the embodiments described above.

In general, a suture delivery device embodying aspects of thisdisclosure may include suitable elements to produce relative movementbetween a proximal region of the device and the expanded profile region,allowing tissue to be secured between the regions and provide a targetfor needle-deployed sutures carried by the device. Such relativemovement between the distal region and the proximal region may involvemovement of the distal region towards the proximal region, movement ofthe proximal region towards the distal region, or both. Further, aspectsinvolving the placement of the sutures, including one or more of thedeployment of the distal region, deployment of the proximal region,securing tissue between the distal and proximal regions, firing of theneedles to place the sutures, capture of the needles after passingthrough the secured tissue, retraction of the deployed regions beforewithdrawal and withdrawal of the device may be performed independentlyor in combination with others.

Embodiments described above have generally been in the context of anexpanding distal region formed by needle deployment member 110. However,as will be appreciated, any suitable structure that may undergo aconformational change from a reduced profile for insertion to anexpanded profile for stabilizing tissue during suture placement may beused. As such, a mechanical foot or base may be used as desired. Inanother aspect, an inflatable balloon may be employed as depicted inFIG. 27. Catheter 600 may be integrated with needle actuating andcapturing elements described above and includes a distal expandingregion in the form of balloon 602. The expanded profile of balloon 602is shown in phantom and may be achieve by use of a suitable inflationfluid. Catheter 600 may employ a multi-lumen configuration to providecommunication for the inflation fluid. Further, a bleed back lumen maybe in communication with distal port 604 to facilitate correctpositioning of balloon 602 within a patient's vessel. Catheter 600 mayfeature an atraumatic distal tip 606 to facilitate introduction.

Another aspect of this disclosure involves needle and suture designs.The embodiments described above have been in the context of a one-pieceneedle design. Alternatively, a detachable needle tip carrying thesuture may be employed. As shown in FIG. 28, a suitable design mayfeature a needle base 700 having a detachable tip 702 carrying suture704. Tip 702 may have a recess configured to fit over post 706 to securethe tip and suture during deployment and delivery. Subsequently, needlebase 700 may be retained, such as by lower band 158 while tip 702 iscaptured, such as by interaction between sheath 128 and catcher 130.Post 706 may have an asymmetrical configuration, such as with ribs 708,to retain tip 702 in a desired rotational orientation. In anotherembodiment, the needle tip may include a post that is received by amatching receptacle in the needle base.

When suture carried tip 702 and needle base 700 enter into spacingbetween sheath and catcher/receiver at the end of needle piercing,needle base 700 may be retracted to distal end of device while suturecarried tip 702 is retained in the space created by sheath andcatcher/receiver.

Described herein are certain exemplary embodiments. However, one skilledin the art that pertains to the present embodiments will understand thatthe principles of this disclosure can be extended easily withappropriate modifications to other applications.

What is claimed is:
 1. A suture delivery device for percutaneouslysuturing tissue comprising: an elongated deployment member having aguide member coaxially disposed over a shaft member; a needle deploymentmember carried at a distal end of the elongated deployment member, theneedle deployment member having at least one deflectable wing, wherein aproximal end of the needle deployment member is secured to the guidemember and a distal end of the needle deployment member is secured tothe shaft member; and a plurality of needles releasably secured to theneedle deployment member, wherein the needle deployment member isconfigured to transition between an uncompressed configurationcorresponding to a first distance between the proximal and distal endsthat longitudinally aligns the plurality of needles with the shaftmember and a compressed configuration corresponding to a second distancebetween the proximal and distal ends that positions the plurality ofneedles at a piercing angle in a proximal direction, the first distancebeing greater than the second distance.
 2. The suture delivery device ofclaim 1, wherein relative longitudinal movement of the shaft member withrespect to the guide member transitions the needle deployment memberbetween the uncompressed and compressed configurations.
 3. The suturedelivery device of claim 1, wherein each of the deflectable wings have aslot configured to carry one of the plurality of needles.
 4. The suturedelivery device of claim 3, wherein the needle deployment member furthercomprises a lower band configured to retain a non-piercing end of eachof the plurality of needles and an upper band configured to position theplurality of needles at the piercing angle when in the compressedconfiguration.
 5. The suture delivery device of claim 2, wherein theelongated deployment member further comprises a sheath member coaxiallydisposed over the guide member, the sheath member configured to extendover a proximal portion of the plurality of needles positioned at thepiercing angle when the sheath member is advanced distally over theguide member.
 6. The suture delivery device of claim 5, wherein theelongated deployment member further comprises a catcher member coaxiallydisposed between the guide member and the sheath member, the catchermember configured to capture the plurality of needles positioned at thepiercing angle when the catcher member is advanced distally over theguide member.
 7. The suture delivery device of claim 6, furthercomprising a housing at a proximal end of the elongated deploymentmember configured to provide relative longitudinal movement between theguide member and each of the sheath member, the catcher member and theshaft member.
 8. The suture delivery device of claim 7, wherein thehousing is configured to store a reproducible amount of tension that maybe selectively released to simultaneously move the sheath memberdistally with respect to the guide member and the shaft memberproximally with respect to the guide member.
 9. The suture deliverydevice of claim 1, further comprising a suture catheter secured to thedistal end of the elongated delivery member, wherein the suture catheteris configured to carry suture material that may be threaded through theplurality of needles.
 10. The suture delivery device of claim 9, whereinthe suture catheter is secured to the elongated delivery member by ahinge allowing rotation in one direction.
 11. A method for delivering asuture percutaneously comprising: providing an elongated deploymentmember having a guide member coaxially disposed over a shaft member, aneedle deployment member carried at a distal end of the elongateddeployment member, the needle deployment member having a plurality ofdeflectable wings, wherein a proximal end of the needle deploymentmember is secured to the guide member and a distal end of the needledeployment member is secured to the shaft member and a plurality ofneedles releasably secured to the needle deployment member; advancingthe elongated deployment member percutaneously to a desired position ina patient; and withdrawing the shaft proximally relative to the guidemember to transition the needle deployment member from an uncompressedconfiguration that longitudinally aligns the plurality of needles withthe shaft member to a compressed configuration that extends thedeflectable wings positions the plurality of needles at a piercing anglein a proximal direction.
 12. The method of claim 11, wherein theelongated deployment member further comprises a sheath member coaxiallydisposed over the guide member, further comprising advancing the sheathmember distally over the guide member to extend over a proximal portionof the plurality of needles positioned at the piercing angle to causethe plurality of needles to pierce tissue sandwiched between theextended deflectable wings and a distal end of the sheath.
 13. Themethod of claim 12, wherein advancing the sheath member distally overthe guide member and withdrawing the shaft member proximally within theguide member is performed simultaneously.
 14. The method of claim 13,wherein advancing the sheath member distally and withdrawing the shaftmember proximally is performed by applying an automatically reproducibleamount of force.
 15. The method of claim 12, wherein the elongateddeployment member further comprises a catcher member coaxially disposedbetween the guide member and the sheath member, further comprisingadvancing the catcher member distally over the guide member to capturethe plurality of needles positioned at the piercing angle.
 16. Themethod of claim 15, wherein the needles are captured by friction betweenthe distal end of the sheath and a distal end of the catcher member.further comprising a housing at a proximal end of the elongateddeployment member configured to provide relative longitudinal movementbetween the guide member and each of the sheath member, the catchermember and the shaft member.
 17. The method of claim 16, furthercomprising advancing the shaft member distally with respect to the guidemember after the plurality of needles are captured to transition theneedle deployment member to the uncompressed configuration.
 18. Themethod of claim 17, further comprising simultaneously withdrawing thesheath member and the catcher member proximally with respect to theguide member after the plurality of needles are captured.
 19. The methodof claim 18, further comprising carrying suture material threadedthrough each of the plurality of needles in a suture catheter secured tothe distal end of the elongated delivery member.
 20. The method of claim19, wherein withdrawing the sheath member and the catcher member drawsthe suture material through the tissue.
 21. A suture delivery device forpercutaneously suturing tissue comprising: an elongated deploymentmember having a guide member coaxially disposed over a shaft member; aneedle deployment member carried at a distal end of the elongateddeployment member, comprising a proximal end and a distal end, aplurality of needles releasably secured to the needle deployment member,wherein each needle is routed coaxially within the distal end of theneedle deployment member; and a needle pusher driven by a link coaxiallydisposed within the shaft member, wherein the needle pusher isconfigured to advance each needle through the distal end of the needledeployment member and coaxially over the proximal end of the needledeployment member to position the plurality of needles at a piercingangle in a proximal direction.